Inspection Readiness and Compliance Remediation

Thoughtful planning and preparation are required for successfully managing inspections by regulatory health authorities to reduce the risk of regulatory enforcement actions. Our team of industry experts and former FDA consumer safety officers has the knowledge and experience to develop tailored inspection readiness plans and can support your staff to prepare for positive interactions with inspectors from around the world.

Pharmatech's approach of achieving Compliance Through ScienceĀ®, i.e. employing objective evidence to demonstrate compliance, is directly aligned with the global health authority (e.g. FDA) requirements for quality and product predictability. Our plans are effective, efficient, and capable of demonstrating to the agency that you have a sustainable and fully compliant system.

Inspection Readiness Services include:

  • Inspection readiness planning (e.g. FDA Audits)
  • Inspection simulations including general GMP/GDP and pre-approval mock audits
  • Simulated ISO certification audits
  • Preparation and coaching for inspection support personnel
  • Identification of high-risk areas and development of risk mitigation strategies
  • On-site support and coaching during inspections

Compliance Remediation services include:

  • Prepare responses to observations made by regulatory health authorities (e.g. FDA Form 483, observations provided by health authorities such as MHRA, Health Canada, European Union Member States (EMA), TGA, and ANVISA)
  • Develop remediation plans in response to regulatory health authority inspections (e.g., FDA warning letters, consent decrees, complete response letters related to manufacturing controls and quality management systems)
  • Manage remediation activities